FORM FDA 3511i

FORM FDA 3511i (12/13) PAGE 1 of 13

Firm Name, City & State:

Inspection Date(s):

Investigators:

FEI Number:

FCE Number:

RETORT DESCRIPTION

INSTRUCTIONS

Complete the question blocks below. Draw a diagram of the retort or obtain one from the firm. Attach the diagram to the EIR as an exhibit. Measure and verify retort plumbing – record on this form. Report all pipe sizes as inside diameter (ID). Cross-sectional area = 3.14r2 (r = 1/2 diameter). This report is designed to capture information about unique retort systems that are not specifically mentioned in Part 113.40. These retorts must meet the requirements found in applicable sections of 113.40. The retorts and operating procedures must be carefully evaluated to ensure that they comply with Part 113. Some of the questions in this form are designed to capture information useful in evaluation of the retort system and may not indicate a deviation from LACF Regulations, Part 113. The FDA “Guide to Inspections of Low Acid Canned Foods, Part 2,” should be used as a guide when conducting inspections of unique retort systems. Photographs are an excellent means of enhancing the description of a retort system.

Before entering the interior of the retort, you must confirm with the firm that you are following the firm’s Stan- dard Operating Procedures designed to meet OSHA confined space requirements. If the firm insists that only plant personnel enter the retort, witness the measurement procedure and data collection. To obtain OSHA confined space information and safety procedures, see the confined space presentation on the FDA ORAU web site. If the firm is not aware of the OSHA confined space requirements or does not have a confined space program, DO NOT ENTER THE RETORT.

If problems are found with the firm’s retort equipment or processing system, refer the reader to the Turbo EIR for a narrative description of specific problems with supporting evidence, under “Objectionable Conditions and Management’s Response.” Submit the completed form as an EIR attachment.

RETORT NO. TYPE OF RETORT

Vertical Horizontal

Other

LENGTH OR HEIGHT DIAMETER

RETORT MANUFACTURER:

RETORT MODEL:

IDENTIFY THE PROCESSING MEDIUM: Steam Water Other

EXPLAIN:

PSC Publishing Services (301) 443-6740 EF

PROCESSING IN OTHER UNIQUE RETORT SYSTEMS (Retort Survey)

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION


Firm Name: FEI Number:

PROCESSING MODE:

Static Still Continuous Batch Agitating – End-over-End Axial Rocking Other

DESCRIBE OPERATION:

TEMPERATURE RANGE OF THERMAL PROCESS (E.G., 245/250/260 DEGREES F):

NUMBER OF BASKETS OR CRATES PER RETORT:

COMPUTER CONTROLS

DOES A COMPUTER CONTROL ANY OF THE RETORT FUNCTIONS?

EXPLAIN:

DOES THE FIRM HAVE DOCUMENTATION ON HAND WHICH INDICATES THAT THE COMPUTER SYSTEM HAS BEEN VALIDATED?

EXPLAIN:

IS RECORD KEEPING PART OF THE COMPUTER FUNCTION?

IF YES, DOES THE RECORD KEEPING COMPLY WITH 21 CFR PART 11?

EXPLAIN:

Yes No ......................................................................

Yes No .....................................................................................................

..................................................................................

Yes No ................................................................

No Yes

AGITATION

IS THE AGITATING RETORT OPERATED IN THE STILL MODE?

COMMENTS:

N/A Yes No ................................................................

IS THE POSITION OF THE CRATE IN THE RETORT CRITICAL TO THE COME-UP AND/OR THERMAL PROCESS?

EXPLAIN:

...................................................................................................................... No N/A Yes



(B) A DESIGN THAT ENSURES THAT THE ACCURACY OF THE DEVICE IS NOT AFFECTED BY ELECTROMAGNETIC INTERFERENCE AND ENVIRONMENTAL CONDITIONS?

COMMENTS:

..........................................................

IS THE TID REPAIRED OR REPLACED WHEN FOUND DEFECTIVE OR INCAPABLE OF BEING ADJUSTED TO THE ACCURATE CALIBRATED REFERENCED DEVICE?

COMMENTS:

.................................................................... No Yes

Yes No .........................................................

No Yes

COMMENTS:

Yes No ..................................................................COMMENTS:

DOES EACH TID HAVE THE FOLLOWING:

(A) A SENSOR AND A DISPLAY? (SHALL REQUIREMENT - 113.40(a)(1))

EXPLAIN HOW THE RETORT CRATE POSITION WAS DETERMINED:

EXPLAIN HOW THE RETORT ROTATION SPEED IS DETERMINED:

EXPLAIN HOW THE RETORT ROTATION SPEED IS RECORDED:

TEMPERATURE-INDICATING DEVICES

IS THE RETORT EQUIPPED WITH A TEMPERATURE-INDICATING DEVICE (TID) THAT ACCURATELY INDICATES THE TEMPERATURE DURING PROCESSING?

COMMENTS:

.......................................................................................... No Yes

IS EACH TID AND EACH REFERENCE DEVICE MAINTAINED BY THE PROCESSOR TESTED FOR ACCURACY AGAINST A REFERENCE DEVICE FOR WHICH THE ACCURACY IS TRACEABLE TO A NATIONAL METROLOGY INSTITUTE, SUCH AS THE NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY (NIST), BY APPROPRIATE STANDARD PROCEDURES UPON INSTALLATION AND AT LEAST ONCE A YEAR THEREAFTER? (SHALL REQUIREMENT - 113.40(a)(1))

.............................................. No Yes

COMMENTS:

WHEN A MERCURY-IN-GLASS THERMOMETER IS USED AS THE TID, IS IT EQUIPPED WITH A SCALE THAT DOES NOT EXCEED 17 DEG F/INCH (4 DEG C/CM OF GRADUATED SCALE)?



IS THE TID USED AS THE REFERENCE INSTRUMENT DURING PROCESSING?

COMMENTS:

Yes No ....................................................

IS THE TID INSTALLED WHERE IT CAN BE ACCURATELY AND EASILY READ?

COMMENTS:

...................................................... No Yes

IS THE TID SENSOR INSTALLED IN THE RETORT SHELL

COMMENTS:

][ ]

[ OR IN AN EXTERNAL WELL ATTACHEDTO THE RETORT

DATE THE TID LAST TESTED FOR ACCURACY: .

(Note - To answer Yes to this question, the records must contain the following information per Part 113.100(c): (1) A reference to the tag, seal or other means of identity used by the processor to identify the TID; (2) The name of the TID manufacturer; (3) The identity of the reference device, equipment and procedures used for the accuracy test and to adjust the TID; (4) If the TID accuracy test is conducted by an outside facility, a guarantee, certificate of accuracy, certificate of calibration, or other document from the facility that includes a statement or other documentation regarding the traceability of the accuracy test to a National Institute of Standards and Technology (NIST) or other national metrology institute standard; (5) The identity of the person or facility that performed the accuracy test and adjusted or calibrated the TID; (6) The date and results of each accuracy test including the amount of calibration adjustment; and (7) The date on or before which the next accuracy test must be performed.

DOES EACH TID AND EACH REFERENCE DEVICE MAINTAINED BY THE PROCESSOR HAVE A TAG, SEAL OR OTHER MEANS OF IDENTITY INDICATING WHEN THEY WERE LAST TESTED FOR ACCURACY?

No Yes

Yes No .....................................................................................................................................................................

ARE ACCURACY RECORDS OF THE TID AND REFERENCE DEVICE MAINTAINED BY THE PROCESSOR ESTABLISHED AND MAINTAINED IN ACCORDANCE WITH PART 113.100(c) AND (d)? ...........................................

In addition, Part 113.100(d) requires that records of accuracy of a reference device maintained by the processor shall include: (1) A reference to the tag, seal or other means of identity used by the processor to identify the reference device; (2) The name of the manufacturer of the reference device; (3) The identity of the equipment and reference to procedures used for the accuracy test and to adjust or calibrate the reference device; or (4) If an outside facility is used to conduct the accuracy test for the reference device, a guarantee, certificate of accuracy, certificate of calibration, or other document from the facility that includes a statement or other documentation regarding the traceability of the accuracy to a NIST or other national metrology institute standard; (5) The identity of the person or facility that performed the accuracy test and adjusted or calibrated the referenced device; (6) The date and results of each accuracy test including the amount of calibration adjustment; and (7) The date on or before which the next accuracy test must be performed.

COMMENTS:

DATE THE TID LAST TESTED FOR ACCURACY: .

STANDARD USED FOR THE TEST:

NAME AND TITLE OF PERSON WHO PERFORMED TEST:

IS THE LAST TEST DATE IDENTIFIED ON THE TID?

COMMENTS:

DESCRIBE THE FIRM’S ACTIONS REGARDING TIDs THAT WERE OUT OF CALIBRATION:

Yes No ....................................................................................................



IS THE TID LOCATED WHERE IT IS EASY TO READ ACCURATELY?

COMMENTS:

THE INDICATOR SENSOR BULB IS LOCATED IN THE SYSTEM

Retort Shell External Well After the Heat Exchanger Before the Heat Exchanger

DESCRIBE THE LOCATION OF THE INDICATOR SENSOR(S):

HOW DOES THE FIRM ENSURE THAT THE TEMPERATURE INDICATED IS REPRESENTATIVE OF THE ACTUAL PROCESSING TEMPERATURE?

.......................................................................... No Yes

TEMPERATURE RECORDER

TYPE OF TEMPERATURE RECORDING: Analog Digital

COMMENTS:

IS THE TEMPERATURE CHART ADJUSTED TO AGREE AS NEARLY AS POSSIBLE WITH BUT NOT HIGHER THAN THE KNOWN ACCURATE TID DURING THE PROCESSING PERIOD?

(SHALL REQUIREMENT – 113.40(b)(2). NOTE ANY DIFFERENCE BETWEEN THE RECORDING THERMOMETER AND THE TID AND WHICH READING IS HIGHER.)

COMMENTS:

IS THERE A MEANS OF PREVENTING UNAUTHORIZED ADJUSTMENTS?

(A MEANS OF PREVENTING UNAUTHORIZED CHANGES IN ADJUSTMENTS SHALL BE PROVIDED. A LOCK OR NOTICE FROM MANAGEMENT STATING “ONLY AUTHORIZED PERSONS ARE PERMITTED TO MAKE ADJUSTMENTS,” POSTED AT OR NEAR THE RECORDING DEVICE, IS A SATISFACTORY MEANS OF PREVENTING UNAUTHORIZED CHANGES – 113.40(b)(2).)

COMMENTS:

No Yes

............................................................... No Yes

...........................................................................

IS THE CHART DRIVE TIMING MECHANISM ACCURATE?

COMMENTS:

.......................................................................................... No Yes

IS THE RECORDER COMBINED WITH A STEAM CONTROLLER?

COMMENTS:

Yes No ................................................................................



THE TEMPERATURE RECORDER SENSING BULB IS INSTALLED IN THE


EXPLAIN:

TEMPERATURE (STEAM) CONTROLLER

IS THE STEAM CONTROLLER AUTOMATIC?

COMMENTS:

HOW IS TEMPERATURE CONTROLLED IN THE RETORT?

Recorder Controller Cam Controller Manual Switching Computer Other

EXPLAIN:

............................................................................................................... No Yes

WHERE IS THE CONTROLLER SENSOR LOCATED?


EXPLAIN:

REPORT THE MANUFACTURER, MODEL, TYPE AND SIZE OF THE AUTOMATIC STEAM CONTROL VALVE:

IF THE TEMPERATURE (STEAM) CONTROLLER IS AIR OPERATED, DOES THE SYSTEM HAVE AN ADEQUATE FILTER TO ASSURE A SUPPLY OF CLEAN, DRY AIR?

(AIR OPERATED TEMPERATURE CONTROLLERS SHOULD HAVE ADEQUATE FILTER SYSTEMS TO ASSURE A SUPPLY OF CLEAN, DRY AIR 113.40(a)(4).)

COMMENTS:

............................................................. No Yes

DURING THE INSPECTION, WAS THERE ANY EVIDENCE OF TEMPERATURE DROPS?

EXPLAIN:

.......................................... No Yes



COME-UP PROCEDURE

DESCRIBE THE FIRM’S PROCEDURE TO BRING THE RETORT UP TO PROCESSING TEMPERATURE. INCLUDE TIME, TEMPERATURE, REMOVAL OF AIR FROM THE SYSTEM AND NUMBER OF STEPS:

CAN THE FIRM DOCUMENT ALL STEPS OF THE COME-UP PROCEDURE?

COMMENTS:

DOES THE FIRM IDENTIFY PROCESS COME-UP STEPS AS CRITICAL ON THE PROCESSING FILING FORMS?

(NOTE – PROCESSING STEPS ARE REQUIRED ON THE PROCESS FILING FORM WHEN THEY HAVE BEEN IDENTIFIED AS CRITICAL TO THE THERMAL PROCESS. THIS IS ALWAYS THE CASE WHEN THE GENERAL METHOD IS USED TO CALCULATE THE FO .)

COMMENTS:

RETORT PLUMBING AND EQUIPMENT ISSUES

WHEN WAS THE LAST MAJOR OVERHAUL OR MAINTENANCE PERFORMED ON THE RETORTS?

COMMENTS:

DOES THE FIRM CONDUCT A RETORT SURVEY PERIODICALLY (YEARLY), OR AFTER A MAJOR RETORT OVERHAUL OR AFTER MAINTENANCE IS PERFORMED ON CRITICAL EQUIPMENT (RETORTS, FILLER, BOILER CONFIGURATION, ETC.)? A RETORT SURVEY IS NOT REQUIRED BY THE REGULATIONS, BUT IS COMMONLY USED TO DOCUMENT THAT A FIRM’S PROCESSING SYSTEM IS IN COMPLIANCE WITH FDA REGULATIONS AND THAT THE SYSTEM MEETS THE SAME CRITERIA (VALVE TYPE, STEAM SPREADER CONFIGURATION, ETC.) AS WHEN TEMPERATURE DISTRIBUTION STUDIES WERE CONDUCTED.

COMMENTS:

DO THE BOILERS SUPPLY SUFFICIENT STEAM TO THE RETORTS?

IS THERE SUFFICIENT PRESSURE IN THE HEADER PIPE SUPPLYING STEAM TO THE RETORTS, ESPECIALLY WHEN MORE THAN ONE RETORT IS BEING VENTED SIMULTANEOUSLY?

COMMENTS:

Yes No ...............................................................

.... No Yes

Yes No ..........................................................................

............................................................... No Yes



HEAT/TEMPERATURE DISTRIBUTION

HAVE TEMPERATURE DISTRIBUTION STUDIES BEEN PERFORMED ON THE FIRM’S RETORTS?

EXPLAIN AND PROVIDE COPIES OF SUPPORTING DOCUMENTS:

DATE OF LAST TEMPERATURE DISTRIBUTION STUDY:

HAS A TEMPERATURE DISTRIBUTION STUDY BEEN PERFORMED ON EACH INDIVIDUAL RETORT?

COMMENTS:

HAS A TEMPERATURE DISTRIBUTION STUDY BEEN PERFORMED ON EACH CONTAINER SIZE?

COMMENTS:

HAS A TEMPERATURE DISTRIBUTION STUDY BEEN PERFORMED ON EACH CONTAINER TYPE (E.G., GLASS, METAL, PLASTIC)?

IF NO, IDENTIFY THOSE WHICH WERE TESTED:

HAS A TEMPERATURE DISTRIBUTION STUDY BEEN PERFORMED ON EACH INDIVIDUAL PRODUCT OR PRODUCT TYPE (E.G., SEAFOOD SOUP VERSUS CANNED TUNA)? IF NO, IDENTIFY THOSE TESTED

COMMENTS:

DID EACH TEMPERATURE DISTRIBUTION STUDY IDENTIFY A COLD SPOT IN THE RETORT?

PROVIDE LOCATION AND EXPLAIN:

Yes No .........................

No ................. Yes

Yes....................... No

No ........................................................................................................................ Yes

No ......... Yes

Yes............................ No



HAVE TEMPERATURE DISTRIBUTION STUDIES BEEN PERFORMED WITH PARTIAL LOADS?

COMMENTS:

HAVE THERE BEEN ANY CHANGES TO THE RETORTS OR THERMAL PROCESSING SYSTEM SINCE THE LAST TEMPERATURE DISTRIBUTION STUDY THAT COULD AFFECT TEMPERATURE DISTRIBUTION?

(THE RETORT DESIGN, LOADING CONFIGURATION, SMALLEST CONTAINER SIZE AND MANY OTHER FACTORS CAN AFFECT THE ATTAINMENT OF TEMPERATURE DISTRIBUTION IN THE RETORT – SEE PP. 21-22 OF LACF GUIDE, PART 2. A CHANGE IN ANY OF THESE FACTORS COULD NECESSITATE A NEW TEMPERATURE DISTRIBUTION STUDY AND POSSIBLY A NEW VENT SCHEDULE. IF A CHANGE HAS BEEN MADE IN THE THERMAL PROCESSING SYSTEM THAT COULD AFFECT TEMPERATURE DISTRIBUTION, THE FIRM SHOULD HAVE ON FILE DOCUMENTATION OF THE CHANGE, INCLUDING THE REVIEW AND APPROVAL BY A QUALIFIED PROCESS AUTHORITY.)

COMMENTS:

Yes.............................. No

No ............... Yes

HAVE TEMPERATURE DISTRIBUTION STUDIES BEEN PERFORMED TO DETERMINE THE EFFECTS OF LOW WATER FLOW?

REPORT RESULTS:

Yes........................................................................................................ No N/A

ARE PARTIAL LOADS PROCESSED IN THE FIRM’S RETORTS?

COMMENTS:

ARE BAFFLE PLATES OR DUMMY LOADS USED DURING THE PROCESSING OF PARTIAL LOADS?

EXPLAIN:

Yes................................................................................. No

No .................. Yes

HAVE TEMPERATURE DISTRIBUTION STUDIES BEEN PERFORMED TO DETERMINE THE EFFECTS OF TEMPERATURE DROPS DURING COME-UP AND PROCESSING?

REPORT RESULTS:

No .............................................. Yes


FORM FDA 3511i (12/13) PAGE 10 of 13

ARE CONTAINERS PROCESSED WITHOUT DIVIDER PLATES?

DESCRIBE STACKING ARRANGEMENT (E.G., BRICK, OFFSET, JUMBLE):

IS CONTAINER NESTING POSSIBLE?

HOW DOES FIRM CONTROL NESTING OF CONTAINERS?

Yes................................................................................. No

No ............................................................................................................................ Yes

IS THE SAME TYPE OF DIVIDER PLATE USED FOR ALL CONTAINERS?

DESCRIBE DIFFERENCES:

No ................................................................... Yes

ARE CONTAINERS POSITIONED IN THE RETORT AS SPECIFIED IN THE SCHEDULED PROCESS?

COMMENTS:

ARE DIVIDERS, TRAYS, RACKS OR OTHER MEANS OF POSITIONING FLEXIBLE CONTAINERS DESIGNED AND EMPLOYED TO ENSURE EVEN CIRCULATION OF HEATING MEDIUM AROUND ALL CONTAINERS?

COMMENTS:

ARE DIVIDER PLATES USED?

DESCRIBE NUMBER OF HOLES AND DISTRIBUTION IN DIVIDER PLATES:

Yes..................... No

No ........... Yes

Yes......................................................................................................................................... No

RETORT CRATES AND RACKS

DESCRIBE THE RETORT CRATES.

DIMENSIONS:

NUMBER OF HOLES:

SIZE OF HOLES:

LOCATION OF HOLES:

DOES THE FIRM PROCESS?

Metal Cans

Glass Jars

Pouches

Rigid Plastic

COMMENTS:

Yes............................ No

No ............................ Yes

Yes............................ No

No ............................ Yes

FORM FDA 3511i (12/13) PAGE 11 of 13


DOES THE FIRM PROCESS MORE THAN ONE CONTAINER SIZE?

LIST ALL CONTAINER SIZES:

METAL CANS:

GLASS JARS:

POUCHES:

SEMI-RIGID PLASTIC:

IF MORE THAN ONE CONTAINER SIZE OR TYPE IS PROCESSED AT ONE TIME, DESCRIBE PROCEDURE USED:

FOR RETORT POUCHES, ARE TRAYS ADEQUATELY DESIGNED WITH POCKETS SUFFICIENT TO CONTAIN AND RESTRAIN INDIVIDUAL POUCHES DURING COME-UP AND PROCESSING?

COMMENTS:

ARE TRAYS OR DIVIDER PLATES IN GOOD CONDITION WITH NO SHARP OR ROUGH POINTS THAT COULD PUNCTURE CONTAINERS?

COMMENTS:

PRESSURE CONTROL

ARE PRODUCTS PRODUCED USING OVER-PRESSURE?

IS THE RETORT EQUIPPED WITH A PRESSURE GAGE?

COMMENTS:

DESCRIBE THE LOCATION WHERE COMPRESSED AIR ENTERS THE RETORT:

IS THE COMPRESSED AIR USED FOR OVER-PRESSURE HEATED PRIOR TO INTRODUCTION INTO THE RETORT?

COMMENTS:

IS A DIFFUSER USED ON THE COMPRESSED AIR ENTRY LINE TO ENSURE RAPID MIXING OF THE AIR IN THE RETORT ATMOSPHERE?

COMMENTS:

LIST THE OVER-PRESSURES USED (E.G., 30 PSI AT 140°C, 36 PSI AT 150°C):

Yes................................... No

Yes................................................................................ No

No ............................................................................................ Yes

Yes............................................................................................. No

No ............................................................................................................................. Yes

Yes...................................................................................... No

Yes No ............................................................................

FORM FDA 3511i (12/13) PAGE 12 of 13


HAS THE POINT WHERE AIR ENTERS THE RETORT BEEN IDENTIFIED AS A COLD SPOT IN THE RETORT?

COMMENTS:

DESCRIBE HOW PRESSURE IS CONTROLLED IN THE RETORT DURING THERMAL PROCESSING:

HAS OVER-PRESSURE BEEN IDENTIFIED AS A FACTOR CRITICAL TO THE THERMAL PROCESS?

COMMENTS:

ARE PRESSURE DROPS CONSIDERED TO BE PROCESS DEVIATIONS?

WHY?/WHY NOT?

CONTAINER COOLING

CONTAINERS ARE COOLED BY: Air Water

EXPLAIN CONTAINER COOLING:

TYPE OF VALVE ON WATER COOLING LINES:

WERE WATER COOLING LINES NOTED TO BE LEAKING?

COMMENTS:

DRAIN LINES

ARE SCREENS USED OVER ALL DRAIN LINES TO PREVENT CLOGGING?

COMMENTS:

No ....... Yes

Yes..................... No

No ................................................................. Yes

............................................................... No Yes

No ......................................................................................... Yes

IS THE DRAIN LINE VALVE WATER TIGHT AND NON-CLOGGING?

COMMENTS:

............................................................................. No Yes

OTHER CONCERNS AND OBSERVATIONS

PLEASE EXPLAIN ANY OTHER CONCERNS WITH THE OPERATION OF THIS RETORT SYSTEM:


FORM FDA 3511i (12/13) PAGE 13 of 13

Documents

FORM FDA 3511i